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Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04433988
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : January 20, 2022
Information provided by (Responsible Party):
Mahmoud Samy Abdallah, Sadat City University

Brief Summary:
With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells. Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation, homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for COVID-19 patients.

Condition or disease Intervention/treatment Phase
COVID Drug: Pentoxifylline Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients
Estimated Study Start Date : November 13, 2022
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Control group
100 patients will receive standard treatment plus placebo
Drug: Placebo
Placebo tablet

Experimental: Pentoxifylline group
100 patients will receive standard treatment plus pentoxifylline 1200 mg/day
Drug: Pentoxifylline
Pentoxifylline 400 mg SR tablet

Primary Outcome Measures :
  1. Primary Outcome [ Time Frame: 7 days ]
    Number of Participants need hospitalization

Secondary Outcome Measures :
  1. Respiratory infection [ Time Frame: 7 days ]
    Incidence of any acute respiratory infection

  2. Serious Adverse Events [ Time Frame: 7 days ]
    Absolute and relative frequencies of Serious Adverse Events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Positive COVID-19 test
  • Age >/= 18 y.o.

Exclusion Criteria:

  • Allergic reaction to Pentoxifylline
  • Ongoing anticoagulation
  • History of GI bleeding
  • History of Seizures
  • Cardiac or other vascular stents
  • History of severe renal disease
  • History of intracranial hemorrhage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04433988

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Contact: Mahmoud S Abdallah, PhD 00201063340887

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Faculty of Medicine
Shibīn Al Kawm, Egypt
Sponsors and Collaborators
Sadat City University
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Responsible Party: Mahmoud Samy Abdallah, Lecturer of Clinical Pharmacy, PhD., Sadat City University Identifier: NCT04433988    
Other Study ID Numbers: RC-6-2020
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers